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clinical_trial_results_template.json
66 lines · skills/clinical-reports/assets/clinical_trial_results_template.json at 5f2bc03
1{
2 "schema_version": "2.0",
3 "artifact_kind": "randomized_trial_results_draft",
4 "draft_status": "BLOCKED_INCOMPLETE_DRAFT_NOT_FOR_PUBLICATION_OR_SUBMISSION",
5 "safety_notice": "This manifest tracks CONSORT item coverage only. It cannot design analyses, create results, infer participant flow, assess harms, or establish trial validity.",
6 "data_classification": "aggregate",
7 "authorized_purpose": null,
8 "authorization_verified": false,
9 "guidance": {
10 "base": "CONSORT 2025",
11 "item_count": 30,
12 "statement_and_explanation_checked": false,
13 "applicable_extensions": [],
14 "applicable_extensions_reviewed": false,
15 "extension_conflicts_resolved_by_methodologist": false
16 },
17 "study_metadata": {
18 "protocol_reference": null,
19 "sap_reference": null,
20 "registry_reference": null,
21 "data_cut_reference": null,
22 "analysis_output_reference": null
23 },
24 "checklist_items": {
25 "C01": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
26 "C02": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
27 "C03": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
28 "C04": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
29 "C05": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
30 "C06": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
31 "C07": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
32 "C08": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
33 "C09": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
34 "C10": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
35 "C11": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
36 "C12": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
37 "C13": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
38 "C14": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
39 "C15": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
40 "C16": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
41 "C17": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
42 "C18": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
43 "C19": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
44 "C20": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
45 "C21": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
46 "C22": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
47 "C23": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
48 "C24": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
49 "C25": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
50 "C26": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
51 "C27": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
52 "C28": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
53 "C29": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
54 "C30": {"status": "missing", "source_fact_ids": [], "official_item_locator": null}
55 },
56 "not_applicable_rationales": {},
57 "participant_flow_source_fact_ids": [],
58 "provenance_manifest": null,
59 "review": {
60 "accountable_author_review": "pending",
61 "methodologist_review": "pending",
62 "statistical_review": "pending",
63 "safety_review": "pending",
64 "publication_authorized": false
65 }
66}